MAUDE Adverse Event Report: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT265

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device manufacture date (mm/dd/yyyy): 02/22/2019 (serial number: (b)(4)), 06/20/2019 (serial number: (b)(4)).We are currently in the process of obtaining the complaint rt265 infant dual heated evaqua2 breathing circuits for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(4) reported, via a fisher & paykel healthcare (f&p) field representative, that two rt265 infant dual heated evaqua2 breathing circuits swivel came loose.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Section h4: device manufacture date (mm/dd/yyyy): 02/22/2019 (serial number:(b)(6), 06/20/2019 (serial number: (b)(6).Method: the complaint rt265 infant dual heated evaqua2 breathing circuits swivels were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the customer's description of event, photography and our knowledge of our product.Conclusion: the customer reported that the swivels of two rt265 circuits came loose.Without the complaint devices, we could not determine what caused the rt265 swivels to disassemble.The infant swivel is assembled using a machine to ensure a consistent tightness of connection.All rt265 infant dual-heated evaqua2 breathing circuits are designed to conform to iso:5367.All rt265 circuits are visually inspected, pressure and flow tested during production and those that fail, are rejected.The user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuit also state the following: - "check all connections are tight before use." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "set appropriate ventilator alarms.".

Event Description

A healthcare facility in minnesota reported, via a fisher & paykel healthcare (f&p) field representative, that two rt265 infant dual heated evaqua2 breathing circuits swivel came loose.There was no reported patient consequence.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 9579077
• MDR Text Key: 182356402
• Report Number: 9611451-2020-00046
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT265
• Device Catalogue Number: RT265
• Device Lot Number: 2100707836,2100801533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1